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Immunomodulatory Properties of Ketamine in Sepsis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01089361
First Posted: March 18, 2010
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniel Talmor, Beth Israel Deaconess Medical Center
  Purpose
The aim of the study is to assess the effect of short-term infusion of ketamine at analgesic dosage on the immune response, morbidity and mortality among patients suffering from septic shock. We hypothesize that ketamine will modulate the cytokine response to sepsis and reduce morbidity and mortality.

Condition Intervention Phase
Sepsis Drug: Ketamine Drug: Normal Saline placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immunomodulatory Properties of Ketamine in Sepsis

Resource links provided by NLM:


Further study details as provided by Daniel Talmor, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Serum Levels of IL-6, IL-10 and TNFα [ Time Frame: first 7 days of admission, Baseline and Day 7 reported ]

Secondary Outcome Measures:
  • Adverse Effects Attributable to Ketamine [ Time Frame: 7 days ]
  • Organ Failures [ Time Frame: 7 days ]
    Incidence of new organ failure as detected by Sequential Organ Failure Assessment [SOFA] score. Definitions are as follows. Central nervous system: delirium, coma, uncontrollable seizures, ICP>20cm H2O Cardiac: MAP <60mmHg, blood pressure supported with pressors, 50 > HR > 120 Respiratory: vented, RR>30, PaO2<60, PaCO2 > 55, Sat<92% Kidney: RIFLE criteria Anemia: Hct<27, transfusion of PRBC Thrombocytopenia: platelet < 50k, platelet transfusion Liver: biopsy, ALT>200, AST>200, t.bil>2.0, ALP>300 Coagulation failure: INR>2 if no anticoagulation therapy

  • Acute Physiology and Chronic Health Evaluation (APACHE) Scores [ Time Frame: First 24 hours after ICU admission ]
    Difference in average APACHE-II score between the intervention and placebo groups. APACHE II (Acute Physiology and Chronic Health Evaluation II) is a severity of disease classification system for patients admitted to the Intensive Care Unit. It uses an integer score from 0 to 71 that is computed based on age, 12 routine physiological measurements (i.e. heart rate, temperature, laboratory values), and previous health status obtained during the first 24 hours after ICU admission. Higher scores correspond to more severe disease and a higher risk of death.

  • Length of Intensive Care Unit (ICU) Stay [ Time Frame: 28 days ]
  • 28 Day Mortality [ Time Frame: 28 days ]

Other Outcome Measures:
  • PCR Substudy [ Time Frame: Daily up to 7 days ]
    PCR analysis on serum samples for presence of bacterial and mitochondrial DNA; This substudy was not done.


Enrollment: 19
Study Start Date: December 2009
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Normal saline placebo
The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
Drug: Normal Saline placebo
The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
Other Name: 0.9% Sodium Chloride Solution
Experimental: Ketamine
The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
Drug: Ketamine
The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
Other Names:
  • Ketamine Hydrochloride
  • Ketalar

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients meeting the ACCP/ SCCM definition of severe sepsis will be enrolled in the study. These patients should have a known or suspected source of infection.
  • Patients within 12 hours of the development of one or more organ dysfunctions
  • Patients must exhibit 3 or more of the following signs of clinical inflammation:

    • Core temperature < 36ºC or > 38ºC.
    • Heart rate of 90 or greater not explained by another medical condition.
    • A respiratory rate of > 20 min-1, a PaCO2 < 32min-1 or the need for mechanical ventilation.
    • A white blood cell count of < 4000 cell/ml or > 12000 cells/ml or a WBC showing greater then 10% immature neutrophils.

Exclusion Criteria:

  • pregnant
  • increased intracranial pressure or closed head injury
  • history of psychotic mental disease
  • receiving Continuous Veno - Venous Hemofiltration
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089361


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Daniel Talmor, MD, MPH Beth Israel Deaconess Medical Center
  More Information

Publications:
Responsible Party: Daniel Talmor, Professor of Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01089361     History of Changes
Other Study ID Numbers: 2009P000259
First Submitted: March 12, 2010
First Posted: March 18, 2010
Results First Submitted: December 22, 2015
Results First Posted: August 21, 2017
Last Update Posted: August 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Daniel Talmor, Beth Israel Deaconess Medical Center:
systemic inflammatory syndrome
sepsis syndrome
septic shock
Cytokine
Ketamine

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action